MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH; SURGICAL MESH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).510k: this report is for an unk - vertebral body replacement - mesh: synmesh/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing a spinal procedure in the cervical, thoracic, or lumbar region between january 1, 2000, and december 21, 2019.The purpose of this study was to review the available real-world data (rwd) on patients with surgical procedures in the cervical, thoracic, or lumbar spine using the depuy synthes synmesh system to support the pmcf plan and to describe demographic, procedural, and clinical characteristics and reoperation and revision outcomes.Failed spinal procedure has been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: -7 patients had reoperations 0-3 months from index surgery.-30 patients had revisions 0-3 months from index surgery.-56 patients had revisions 0-12 months from index surgery.-4 patients had revisions 13-24 months from index surgery.This report is for depuy synthes synmesh.This report is for one (1) unk - vertebral body replacement - mesh: synmesh.This is report 3 of 3 for complaint (b)(4).

• Brand Name: UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12712452
• MDR Text Key: 282693428
• Report Number: 2939274-2021-06363
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention